pp-2163-4 paul mueller company pyropure...1.5" tc 2" tc 2" tc 3" tc 3" tc...

PYROPURE® PRODUCTS

BIOPHARM SYSTEMS

1

Paul Mueller Company

S ince our inception in 1940, Paul Mueller Company has evolved from a small-scale fabricator into a global

process solution provider with one million square feet of manufacturing space. Mueller® offers a full range

of tanks from shop-fabricated alloy vessels up through 20 feet in diameter to field-fabricated vessels up

through 2,000,000 gallons; furthermore, Mueller offers integrated systems, modular fabrication, field

construction, plant maintenance and repair, and complete turnkey project execution. Our facility is

uniquely qualified to handle large and complex fluid handling systems from project concept through

installation. Our products are used in over 100 countries in a wide variety of applications. Paul Mueller

Company delivers outstanding equipment and unique solutions to the process industries with our technical

expertise, innovative engineering, and manufacturing resources.

We know that building a quality product starts from the ground up. Our unprecedented purpose is to

make your system as valuable and efficient as it can be, and to guarantee that you receive the highest

possible quality in our processes and products. With our skilled craftsmen, quality materials, and one of

the best technologically advanced manufacturing facilities in the country, we are able to build exceptional

products at a reasonable price.

Mueller products are made by our highly skilled craftsmen, whose average experience exceeds 15 years.

Our process is well defined and consistently developed. Each Mueller team member fully understands

the importance that their individual roles play in producing a quality product. On any given day, their

talent and pride of workmanship can be observed in any of our production areas. Our central United

States production facility lowers your transportation costs and speeds delivery of product to your location.

Mueller Transportation, Inc. allows us to provide you with competitive delivery rates on standard products,

as well as dedicated handling for large or critical delivery items. We offer a perfect package by working

directly with you to resolve any transportation issues.

Mueller Field Operations, Inc. To offer our customers more versatility and flexibility, Mueller’s field

construction capabilities allows us to install our advanced products at a low cost.

Factory technicians and field service available. We offer rapid response to your service needs with trained

factory personnel knowledgeable in all aspects of Mueller equipment.

The Mueller ReputationEvery piece of Mueller PyroPure processingequipment is precision engineered for qualityform and fit, close tolerances, and high qualityfinishes. You can depend on Mueller to delivera product that will perform required functionsand offer reliable product protection.

Get to Know Mueller® PyroPure® Products

2

Our Philosophy is Simple:We are committed to meeting and exceeding our customers’expectations of value by providing high quality equipment,

excellent service, and complete process solutions.

PyroPure Pure Steam Generators

3


The Mueller PyroPure P7000 Series AdvantageMueller PyroPure pure steam generators are capable of producing pyrogen-free pure steam that, when condensed,

meets all U.S. Pharmacopoeia (USP) requirements for use in autoclaves, critical area humidification, and routine steam-

in-place (SIP) sterilization.

Feedwater enters the system and flows through two level control valves and then into the tube side of the blowdown

cooler. In the blowdown cooler, heat is transferred between the feedwater on the tube side and the blowdown exiting

the system through the shell side. Correspondingly, the blowdown exits the system at a lower, safer temperature, and

the feedwater enters the system at a higher, more efficient temperature.

The heated feedwater flows into the steam separator while filling the lower part of the steam separator, the tube side

of the evaporator, and the level indicator assembly to a factory-determined range controlled by level indicator switches.

At the same time, utility steam enters the shell side of the evaporator. Latent heat from steam is rejected to the feedwater

through the walls of the evaporator tubes. The feedwater is evaporated, and the resulting vapor is propelled from the

evaporator into the steam separator where any impurities are removed from the steam by centrifugal force. Pyrogen-

free steam exits from the top center of the separator and feeds the pure steam distribution system.

• An external evaporator provides improved access

for inspection and preventative maintenance on

critical o-rings and gaskets.

• The separation column contains no internal

components that require inspection or periodic

maintenance.

• All maintenance (including replacement of critical

components) can be performed with only 24" of

space on all sides (including the top) of the

equipment.

• Minimal instrumentation is required for equipment

operation. Only one control loop is needed which

minimizes the calibration required, as well as the

potential for downtime.

• All components are fully drainable, including the

feedwater pump.

• All elastomers in contact with feedwater and

product are provided with USP Class VI

certifications.

• ASME BPE certified fittings are used throughout

the design.

• All product contact surfaces are polished to 20 Ra

maximum and electropolished. Surfaces in contact

with feedwater are polished to 25 Ra maximum.

All surfaces in contact with feedwater and product

are manufactured from 316/316L stainless steel.

Simple Design, Reliable Operation

4

System ComponentsEvaporator. The natural circulation design of the PyroPure

double-tubesheet evaporator ensures maximum surface

wetting, eliminating the hot, dry areas that lead to the

stress cr acking associated with other designs. The tube

bundle creates a large heat transfer surface that vaporizes

feedwater almost instantly to allow the unit to respond

to large loads. Mueller PyroPure pure steam generators

have a fully drainable external evaporator, eliminating the

need for the excess headroom required for evaporator

removal with other designs. All surfaces that come into

contact with pure vapor or distillate are made of type

316L stainless steel, including the sanitary clamp-type

connections and seamless tubes.

Blowdown Cooler Assembly. The blowdown cooler

assembly serves two functions in making the PyroPure

pure steam generator as reliable and efficient as possible:

pre-heating the feedwater and cooling blowdown. By

transferring heat from blowdown to incoming feedwater,

the blowdown cooler serves to preheat the feedwater

while cooling wastewater and preventing it from flashing

into steam as it exits the high-pressure separator. Blow-

down temperatures are consistently less than 140°F (60°C)

when constantly fed with ambient temperature feedwater.

Steam Separator. As the mixture of water and vapor

leaves the evaporator at high velocity and enters the steam

separator through a tangential port, a natural vortex is

formed. The centrifugal force of the vortex separates water

droplets and contaminants out of the spiraling vapor. Pure

vapor rises up through the steam separator and out of the

pure steam outlet at the top of the generator. Because the

separator has no baffles or demister, there are no auxiliary

surfaces for condensation to accumulate and stagnate.

Consequently, concerns over potential bacterial growth

are eliminated.

Controls. The standard control system is an Allen Bradley

PLC with an Allen Bradley operator interface mounted in

a NEMA rated panel. Ethernet is provided on the standard

control system to facilitate communications with adjacent

equipment or data archiving systems. Mueller can also

provide other Allen Bradley control components, as well

as control systems from Siemens and Mitsubishi. Control

and electrical panels are supplied with a UL 508a label.

OptionsFeedwater Pump System. The feedwater pump system

enhances feedwater pressure and should be installed if

feedwater supply pressure does not exceed the desired

pure steam operating pressure by 15–30 psig (1–2 bar).

When furnished, the feedwater pump system will be

installed on the pure steam generator framework.

Pure Steam Condensate Sampling System. Regular

product testing for regulatory compliance. The sampling

system will simplify your sampling methods and enab le

you to draw samples for testing. The sample valve is

located near the control box for easy access.

Pure Steam Analyzer. This option works mutually with

the pure steam condensate sampling system to measure

and record the temperature and conductivity of the

condensed pure steam. If the conductivity rises above

the user-selected setpoint, the analyzer will signal an

alarm on the operator interface.

Stainless Steel Sheathing and Frame. Sheathing made

entirely of Type 304 stainless steel enhances the general

appearance of your unit and adds value to any facility.

The sturdy Type 304 stainless steel frame enhances the

generator’s overall appearance, as well as improves the

resistance to corrosion. Standard equipment includes a

painted carbon steel frame and embossed aluminum

insulation sheathing.

Feedwater Analyzer. The feedwater analyzer option

continuously measures and records the conductivity of

the feedwater. If the conductivity rises above the user-

selected setpoint, the analyzer will signal the operator

interface.

Degasser. To ensure compliance with regulations limiting

the non-condensable gas content in pure steam the

degasser may be desired. The degasser uses steam from

the steam separator to heat the feedwater. As the feed-

water is heated the non-condensable gases are expelled

and vented from the equipment.

WFI Production. A pure steam condenser may be

included with the pure steam generator to produce up to

150 gallons per hour (568 LPH) of WFI. The condenser

may be provided integral to the pure steam generator

skid or as a separate skid.

Pu

re s

team

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t

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ut

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am s

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dw

ater

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ana

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ater

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r

The Mueller PyroPure P7000 Series Advantage

5


6

Spec

ifica

tions

Mod

el N

os.

P70

60

P

714

0

P

714

5 P

7310

P

7315

P

750

0

P75

05

P79

90P

7995

Cap

acit

y (l

b/h

r)1

6

00

(272

kg/h

r)

1,3

00

(59

0)

1,

850

(839

)2,

300

(1,0

43)

2,9

00

(1,31

5)4

,00

0(1

,814

)5,

700

(2,5

86

)7,

300

(3,3

11)

10,5

00

(4

,76

3)

FW

Inle

t2,5

1"

TC

1"

TC

1"

TC

1" T

C1"

TC

1" T

C1"

TC

1.5"

TC

1.5"

TC

Pla

nt S

team

Inle

t (

150

psi

g m

ax.)

3

1" F

lang

e

1.5

" F

lang

e

1.5

" F

lang

e2"

Fla

nge

2" F

lang

e3"

Fla

nge

3" F

lang

e4

" F

lang

e4

" F

lang

e

Pur

e St

eam

O

utle

t

1.5"

TC

2" T

C

2

" T

C3"

TC

3" T

C4

" T

C4

" T

C6

" T

C6

" T

C

Con

den

sate

O

utle

t4

.7

5" F

NP

T

1

" F

NP

T

1" F

NP

T1.2

5" F

NP

T1.2

5" F

NP

T1.5

" N

PT

1.5"

NP

T2"

Fla

nge

2" F

lang

e

Dra

in

1

" T

C

1

" T

C

1" T

C1"

TC

1" T

C1"

TC

1" T

C1"

TC

1" T

C

Ins

trum

ent

Air

.25"

FN

PT

.25"

FN

PT

.25"

FN

PT

.25"

FN

PT

.25"

FN

PT

.25"

FN

PT

.25"

FN

PT

.25”

FN

PT

.25"

FN

PT

FW

Pre

ssur

e/

Q

uant

ity

Req

’d.5

Max

imum

of

150

psi

g/M

axim

um o

f 1 p

pm

sili

ca o

r to

tal h

ard

ness

. No

chl

ori

ne, c

hlo

rid

es, o

r am

ines

.

Ele

c. S

rv. (

Std

.)6

Wit

hout

Pum

p: 1

15 V

AC

, 1 p

hase

, 50

/60

Hz.

; Wit

h P

ump

: 46

0 V

AC

, 3 p

hase

, 60

Hz.

(O

ther

vo

ltag

es a

vaila

ble

up

on

req

uest

.)

Hei

ght

7

9

4"(

239

cm)

107"

(272

cm)

107"

(272

cm)

115"

(29

2cm

)11

5"(2

92

cm)

126

"(32

0cm

)12

6"(

320

cm)

143"

(36

3cm

)16

7"(4

24cm

)

Wid

th7

48

"(12

2cm

)

4

8"(

122

cm)

48

"(12

2cm

)50

"(12

7cm

)50

"(12

7cm

)50

"(12

7cm

)50

"(12

7cm

)61

"(15

5cm

61"(

155

cm)

Dep

th7

4

6.5

"(11

8cm

)

46

.5"(

118

cm)

46

.5"(

118

cm)

54.5

"(13

8cm

)54

.5"(

138

cm)

61.5

"(15

6cm

)61

.5"(

156

cm)

63.

5"(1

61cm

)6

3"(1

61cm

)

Op

erat

ing

/

1,

500

lbs

2,15

0lb

s

2,35

0lb

s2

,70

0lb

s2,

80

0lb

s5,

100

lbs

5,70

0lb

s8

190

lbs

920

0lb

s S

hip

pin

g W

t.

(6

80

kg)

(9

80

kg)

(1,0

70kg

)(1

,230

kg)

(1,27

0kg

)(2

,313

kg)

(2,5

80

kg)

(371

0kg

)(3

870

kg)

1C

apac

ity is

bas

ed o

n a

stea

m s

upp

ly p

ress

ure

of 12

0 p

sig

, a p

ure

stea

m h

ead

er p

ress

ure

of 5

0 p

sig

, and

a fe

edw

ater

tem

per

atur

e of

70

°F.

2F

eed

wat

er fl

ow r

ate

mus

t b

e 5

to 10

per

cent

gre

ater

tha

n th

e p

ure

stea

m v

olum

e p

rod

uced

to

allo

w fo

r b

low

dow

n (e

.g.,

100

lb/h

r [1

2 g

ph]

pur

e st

eam

req

uire

s 11

0 lb

/hr

[13.

8 g

ph]

feed

wat

er).

3If

feed

wat

er t

emp

erat

ure

is a

t le

ast

160

°F (

71°C

) th

en p

lant

ste

am m

ust

be

20 p

erce

nt g

reat

er t

han

pur

e st

eam

cap

acity

(e.

g.,

100

lb/h

r p

ure

stea

m r

equi

res

120

lb/h

r p

lant

ste

am).

If fe

edw

ater

tem

per

atur

e is

ap

pro

xim

atel

y 70

°F, t

hen

pla

nt s

team

mus

t b

e 30

per

cent

gre

ater

tha

np

ure

stea

m c

apac

ity.

4G

ener

ator

per

form

ance

cur

ves

assu

me

no b

ack

pre

ssur

e on

the

con

den

sate

out

let.

Any

bac

k p

ress

ure

mus

t b

e su

btr

acte

d fr

om t

he in

let

sup

ply

ste

am p

ress

ure

to fi

gur

e th

e ne

t ef

fect

ive

inle

t st

eam

pre

ssur

e an

d a

ctua

l uni

t p

erfo

rman

ce.

5If

a fe

edw

ater

pum

p is

use

d, f

eed

wat

er m

ust

be

sup

plie

d a

t a

min

imum

pre

ssur

e of

10 p

sig

and

con

nect

ion

size

may

be

larg

er t

han

ind

icat

ed.

6O

ther

ele

ctric

al s

ervi

ces

mus

t b

e sp

ecifi

ed a

t tim

e of

ord

er.

7D

imen

sion

s an

d w

eig

hts

do

not

incl

ude

optio

ns. A

ll sp

ecifi

catio

ns s

ubje

ct t

o ch

ang

e w

ithou

t no

tice.

7


PyroPure Pure Steam Generator Capacity Curves1. Select the chart(s) with pure steam capacities closest to the one you need.

2. Locate your supply steam pressure on the vertical axis.

3. Follow that line across to the point where it intersects with the curve representing your required pure steam

pressure.

4. Drop down from this point to the horizontal axis to determine the model’s pure steam capacity.

5. Select the model which most closely fits your capacity needs given your pressure requirements.

Note: Capacities shown are approximate and do not include an allowance for pure steam sampling.

0 200 400 600 800 1000 1200 1400 1600(91) (181) (272) (363) (454) (545) (636) (726)

140

130

120

110

100

90

80

70

60

50

40

30

20

10

0

(9.7)

(9.0)

(8.3)

(7.6)

(6.9)

(6.2)

(5.5)

(4.8)

(4.1)

(3.5)

(2.8)

(2.1)

(1.4)

(0.7)

Inp

ut

Ste

am S

up

ply

Pre

ssu

re (

bar

)

Pure Steam Capacity lb/hr (kg/hr)

Pure Steam Output Pressure Curve

Model P7140

100 psig (6.9 bar)

338°F (170°C

)

90 psig (6.2 bar)

331°F (166°C

)

80 psig (5.5 bar)

324°F (162°C)

70 psig (4.8 bar)

316°F (158°C)

60 psig (4.1 bar)

307°F (153°C)

50 psig (3.5 bar)

298°F (148°C)

40 psig (2.8 bar)

287°F (142°C)

30 psig (2.1 bar)

274°F (134°C)

20 psig (1.4 bar)

259°F (126°C)

10 psig (0.7 bar)

240°F (116°C)

2500 50 100 150 200 300 350 400 450 500 550 600 650 700 750

140

130

120

110

100

90

80

70

60

50

40

30

20

10

0

(9.7)

(9.0)

(8.3)

(7.6)

(6.9)

(6.2)

(5.5)

(4.8)

(4.1)

(3.5)

(2.8)

(2.1)

(1.4)

(0.7)

(23) (45) (68) (91) (114) (136) (159) (182) (204) (227) (250) (272) (295) (318) (341)

Inp

ut

Ste

am S

up

ply

Pre

ssu

re (

bar

)


Model P7060

100 psig (6

.9 bar)

338°F (170°C

)

90 psig (6

.2 bar)

331°F (166°C

)

80 psig (5.5 bar)

324°F (162°C

)

70 psig (4.8 bar)

316°F (158°C)

60 psig (4.1 bar)

307°F (153°C)

50 psig (3.5 bar)

298°F (148°C)

40 psig (2.8 bar)

287°F (142°C)

30 psig (2.1 bar)

274°F (134°C)

20 psig (1.4 bar)

259°F (126°C)

10 psig (0.7 bar)

240°F (116°C)Pure Steam Output Pressure Curve

0 200 400 600 800 1000 1200 1400 1600(91) (182) (272) (363) (454) (545) (636) (726)

140

130

120

110

100

90

80

70

60

50

40

30

20

10

0

(9.7)

(9.0)

(8.3)

(7.6)

(6.9)

(6.2)

(5.5)

(4.8)

(4.1)

(3.5)

(2.8)

(2.1)

(1.4)

(0.7)

Inp

ut

Ste

am S

up

ply

Pre

ssu

re (

bar

)


100 psig (6.9 bar)

338°F (170°C)

90 psig (6.2 bar)

331°F (166°C)

80 psig (5.5 bar)

324°F (162°C)

70 psig (4.8 bar)

316°F (158°C)

60 psig (4.1 bar)

307°F (153°C)

50 psig (3.5 bar)

298°F (148°C)

40 psig (2.8 bar)

287°F (142°C)

30 psig (2.1 bar)

274°F (134°C)

20 psig (1.4 bar)

259°F (126°C)

10 psig (0.7 bar)

240°F (116°C)


Model P71450 400 800 1200 1600 2000 2400 2800 3200 3600

(182) (363) (545) (726) (908) (1090) (1453) (1634)

140

130

120

110

100

90

80

70

60

50

40

30

20

10

0

(9.7)

(9.0)

(8.3)

(7.6)

(6.9)

(6.2)

(5.5)

(4.8)

(4.1)

(3.5)

(2.8)

(2.1)

(1.4)

(0.7)

Inp

ut

Ste

am S

up

ply

Pre

ssu

re (

bar

)

Pure Steam Capacity lb/hr (kg/hr)(1271)

Model P7310


100 psig (6

.9 bar)

338°F (1

70°C)

90 psig (6

.2 bar)

331°F (1

66°C)

80 psig (5

.5 bar)

324°F (1

62°C)

70 psig (4

.8 bar)

316°F (158°C

)

60 psig (4

.1 bar)

307°F (153°C

)

50 psig (3.5 bar)

298°F (148°C

)

40 psig (2.8 bar)

287°F (142°C)

30 psig (2.1 bar)

274°F (134°C)

20 psig (1.4 bar)

259°F (126°C)

10 psig (0.7 bar)

240°F (116°C)

Pressure and Temperature Charts

8

0 1000 2000 3000 4000 5000 11,0006000 8000 10,00090007000(454) (907) (1361) (1814) (2268) (4990)(2722) (3629) (4536)(4082)(3175)

Inp

ut

Ste

am S

up

ply

Pre

ssu

re (

bar

)


100 psig (6

.9 bar)

338°F (170°C

)

90 psig (6

.2 bar)

331°F (166°C

)

80 psig (5

.5 bar)

324°F (162°C

) 70 psig (4

.8 bar)

316°F (158°C

)

60 psig (4

.1 bar)

307°F (153°C

)

50 psig (3

.5 bar)

298°F (148°C

)

40 psig (2.8 bar)

287°F (142°C)

30 psig (2.1 bar)

274°F (134°C)

20 psig (1.4 bar)

259°F (126°C)

10 psig (0.7 bar)

240°F (116°C)


Model P7990

140

130

120

110

100

90

80

70

60

50

40

30

20

10

0

(9.7)

(9.0)

(8.3)

(7.6)

(6.9)

(6.2)

(5.5)

(4.8)

(4.1)

(3.5)

(2.8)

(2.1)

(1.4)

(0.7)

0

140

130

120

110

100

90

80

70

60

50

40

30

20

10

0

(9.7)

(9.0)

(8.3)

(7.6)

(6.9)

(6.2)

(5.5)

(4.8)

(4.1)

(3.5)

(2.8)

(2.1)

(1.4)

(0.7)

1000 2000 3000 4000 5000 11,0006000 8000 10,00090007000(454) (907) (1361) (1814) (2268) (4990)(2722) (3629) (4536)(4082)(3175)

Inp

ut

Ste

am S

up

ply

Pre

ssu

re (

bar

)


100 psig (6.9 bar)

338°F (170°C)

90 psig (6.2 bar)

331°F (166°C)

80 psig (5.5 bar)

324°F (162°C)

70 psig (4.8 bar)

316°F (158°C)

60 psig (4.1 bar)

307°F (153°C)

50 psig (3.5 bar)

298°F (148°C)

40 psig (2.8 bar)

287°F (142°C)

30 psig (2.1 bar)

274°F (134°C)

20 psig (1.4 bar)

259°F (126°C)

10 psig (0.7 bar)

240°F (116°C)Pure Steam Output Pressure Curve

Model P7995

140

130

120

110

100

90

80

70

60

50

40

30

20

10

00 400 800 1200 1600 2000 2400 2800 3200 3600

(182) (363) (545) (726) (908) (1090) (1271) (1453) (1634)

(9.7)

(9.0)

(8.3)

(7.6)

(6.9)

(6.2)

(5.5)

(4.8)

(4.1)

(3.5)

(2.8)

(2.1)

(1.4)

(0.7)

Inp

ut

Ste

am S

up

ply

Pre

ssu

re (

bar

)


100 psig (6

.9 bar)

338°F (170°C

)

90 psig (6.2 bar)

331°F (166°C)

80 psig (5.5 bar)

324°F (162°C)

70 psig (4.8 bar)

316°F (158°C)

60 psig (4.1 bar)

307°F (153°C)

50 psig (3.5 bar)

298°F (148°C)

40 psig (2.8 bar)

287°F (142°C)

30 psig (2.1 bar)

274°F (134°C)

20 psig (1.4 bar)

259°F (126°C)

10 psig (0.7 bar)

240°F (116°C)


Model P7315

0

140

130

120

110

100

90

80

70

60

50

40

30

20

10

0

(9.7)

(9.0)

(8.3)

(7.6)

(6.9)

(6.2)

(5.5)

(4.8)

(4.1)

(3.5)

(2.8)

(2.1)

(1.4)

(0.7)

500 1000 1500 25002000 3500 45003000 4000 55005000 6000(227) (454) (680) (1134)(9 07) (1588) (2041)(1361) (1814) (2495)(2268)

Inp

ut

Ste

am S

up

ply

Pre

ssu

re (

bar

)


100 psig (6.9 bar)

338°F (170°C)

90 psig (6.2 bar)

331°F (166°C)

80 psig (5.5 bar)

324°F (162°C)

70 psig (4.8 bar)

316°F (158°C)

60 psig (4.1 bar)

307°F (153°C)

50 psig (3.5 bar)

298°F (148°C)

40 psig (2.8 bar)

287°F (142°C)

30 psig (2.1 bar)

274°F (134°C)

20 psig (1.4 bar)

259°F (126°C)

10 psig (0.7 bar)

240°F (116°C)


Model P7505(2722)

0 500 1000 1500 25002000 35003000 4000 55005000 6000(227) (454) (680) (1134)(907) (1588) (2041)(1361) (1814) (2495)(2268) (2722)

140

130

120

110

100

90

80

70

60

50

40

30

20

10

0

(9.7)

(9.0)

(8.3)

(7.6)

(6.9)

(6.2)

(5.5)

(4.8)

(4.1)

(3.5)

(2.8)

(2.1)

(1.4)

(0.7)

Inp

ut

Ste

am S

up

ply

Pre

ssu

re (

bar

)


100 psig (6

.9 bar)

338°F (170°C

)

90 psig (6.2 bar)

331°F (166°C

)

80 psig (5.5 bar)

324°F (162°C

)

70 psig (4.8 bar)

316°F (158°C)

60 psig (4.1 bar)

307°F (153°C)

50 psig (3.5 bar)

298°F (148°C)

40 psig (2.8 bar)

287°F (142°C)

30 psig (2.1 bar)

274°F (134°C)

20 psig (1.4 bar)

259°F (126°C)

10 psig (0.7 bar)

240°F (116°C)

Model P75004500


9


PyroPure Pure Steam Condensing SystemThe Mueller PyroPure P4000 Series AdvantageThe Mueller PyroPure pure steam condensing systems are designed for use by companies in the pharmaceutical and

biotechnological industries who want to use their pure steam generating systems for the production of WFI quality

distillate as well as WFI quality pure steam. When used with a Mueller PyroPure pure steam generator or when fed

WFI quality pure steam from another source, the water produced will be pyrogen free and will meet or exceed the

latest specifications of the USP for water-for-injection (WFI). The condensing system may be provided integral to a

Mueller PyroPure pure steam generator skid or as a separate stand-alone skid. The stand-alone design for the

condensing system allows it to be installed adjacent to a pure steam generator or located remotely at the point of use.

Pure steam enters the system and flows into the shell side of the condenser for the condensation and subcooling to

the required product temperature. Coolant such as chilled water or a glycol solution is used on the tube side of the

condenser for cooling. The final product is measured for conductivity to ensure compliance with specifications.

Control of the condensing system is accomplished by a single control loop. The loop monitors the product temperature

and manipulates a coolant control valve to maintain the specified product temperature.

• WFI condensers have removable tube

bundles for easy cleaning and inspection

of product contact surfaces.

• All maintenance, including replacement

of critical components, can be performed

with only 24" of space on all sides

(including the top) of the equipment.

• All components are fully drainable.

• Minimal instrumentation is required for

operation of the equipment. Only one

control loop is needed which minimizes

the calibration required as well as the

potential for downtime.

• All elastomers in contact with pure steam

and product are provided with USP Class

VI certifications.

• ASME-BPE certified fittings are used

throughout.

• All product contact surfaces are

manufactured from 316/316L stainless

steel polished to 20 Ra maximum and

electropolished.


10

System ComponentsCondenser. Mueller PyroPure condensers have a

double-tubesheet design, providing users with efficient

heat exchange while ensuring pure vapor and distillate

never come into contact with feedwater and coolant.

To facilitate maintenance, all PyroPure condensers are

mounted at an angle to allow full drainage of the pure

distillate through the distillate outlet port installed at

the vessel’s lowest point. The condenser is designed to

allow the removal of the U-tube bundle for easier

inspection of critical pure distillate contact surfaces.

Controls. An Allen Bradley PLC with an Allen Bradley

operator interface mounted in a NEMA rated panel is

the standard control system. Ethernet is provided to

facilitate communication with adjacent equipment or

data archiving systems. Mueller can also provide other

Allen Bradley control components, as well as control

systems from Siemens and Mitsubishi. Control and

electrical panels are supplied with a UL 508a label.

Model Numbers P4001 P4002 P4003 P4004

Capacity, gph (lph)2 25 (95) 50 (189) 100 (379) 150 (568)

Pure Steam Inlet 1.5" TC 1.5" TC 1.5" TC 2" TC

Coolant Inlet/Outlet .75" FNPT .75" FNPT 1" FNPT 1" FNPT

Distillate Outlet 1.5" TC 1.5" TC 1.5" TC 1.5" TC

Instrument Air .25" FNPT .25" FNPT .25" FNPT .25" FNPT

Pure Steam, lb/hr (kg/hr) 202 (92) 403 (183) 807 (366) 1,210 (549)

Coolant, gph (lph)2 241 (912) 486 (1,840) 978 (3,702) 1,470 (5,565)

Electrical Service (Standard)3 115 VAC, 1phase, 50/60 Hz. (Other voltages available upon request)

Height4 106" (269 cm) 108" (274 cm) 111" (282 cm) 111" (282 cm)

Width4 55" (140 cm) 55" (140 cm) 55" (140 cm) 55" (140 cm)

Depth4 37.5" (95 cm) 37.5" (95 cm) 37.5" (95 cm) 37.5" (95 cm)

Distillate Outlet Height4 85" (216 cm) 85" (216 cm) 85" (216 cm) 85" (216 cm)

1 Pure Steam 15–90 psig (1.0–6.2 barg) dry and saturated (capacity based on 45 psig, 3.1 barg).2 Coolant water at 32°F to 100°F (0°C to 38°C) at 40 psig (2.8 barg) (flow rates based upon a distillate outlettemperature of 190°F [88°C] and cooling water inlet temperature of 60°F [16°C]).

3 Other electrical services must be specified at time of order.4 Dimensions for stand-alone system only. For systems integral to a pre steam generator, dimensions will varybased on the model of pure steam generator used. Approximate operating/shipping weight is 2,500lb (1,134 kg).

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Specifications

PyroPure Single-Effect StillsThe Efficient Mueller PyroPure Single-Effect StillMueller PyroPure single-effect stills (SES) are a smaller distillation units designed to meet the needs and budgets of

growing organizations interested in developing new products. The SES is capable of producing up to 50 gallons of

WFI per hour. The SES is manufactured according to FDA current Good Manufacturing Practices (cGMPs). It features

a pharmaceutical vent filter, double-tube-sheet condenser, and evaporator, including stainless steel seamless evaporator

and condenser tubing, and stainless steel steam separator. All components coming into contact with feedwater, pure

vapor, or distillate are made of Type 316 stainless steel, and all welded parts are made of Type 316L stainless steel.

Feedwater enters the system and fills the steam separator, the tube side of the evaporator, and the level indicator

assembly. At the same time, supply steam enters the shell side of the evaporator where it yields its latent heat to the

feedwater through the walls of the evaporator tubes. The feedwater is evaporated, and the resulting vapor is propelled

from the evaporator and into the steam separator where any impurities are centrifuged out. Pyrogen-free steam rises

up through the steam separator and flows into the condenser. The pure steam is condensed by rejecting heat into

cooling water circulating through the tubes of the condenser. The resulting distillate is then drained into a suitable

storage vessel.

11


• External evaporators access for

inspection and preventative maintenance

on critical o-rings and gaskets.

• The separation columns contain no

internal components that require

inspection or periodic maintenance.

• All maintenance, including replacement

of critical components, can be performed

with only 24" of space on all sides

(including the top) of the equipment.

• ASME-BPE certified fittings are used

throughout.

• WFI condensers have removable tube

bundles for easy cleaning and inspection

of product contact surfaces.

• All product contact surfaces are

manufactured from 316/316L stainless

steel polished to 20 Ra maximum and

electropolished.

• All elastomers in contact with feedwater

and product are provided with USP Class

VI certifications.

• All components are fully drainable

including the optional feedwater pump.


Model Numbers SES–15 SES–30 SES–50

Capacity, gph (lph)2 15 30 50

Feedwater Inlet .5" TC .5" TC 1" TC

Plant Steam Inlet .75" FNPT 1" FNPT 1" FNPT

Coolant Inlet/Outlet .5" FNPT .75" FNPT .75" FNPT

Distillate Outlet .75" TC 1" TC 1.5" TC

Instrument Air .25" FNPT .25" FNPT .25" FNPT

Feedwater, gph (lph) 17 33 55

Pure Steam, lb/hr (kg/hr)1 155 308 501

Coolant, ghp (lph)2 138 280 473

Electrical Srv. (Std.)3 115 VAC, 1phase, 50/60 Hz. (Other voltages available upon request)

Height 94" (cm) 103"(cm) 122" (cm)

Width 45" (cm) 45" (cm) 56.5" (cm)

Depth 33.5" (cm) 33.5" (cm) 33.5" (cm)

Distillate Outlet Height 68" (cm) 82" (cm) 97" (cm)

12

Coolant out

Coolant in

TI

Drain

S

T

AE

Distillate out

Distillateto drain

Plant steam in

Condensate out

Feedwater in

PI

PSLS

FCV

PI

Schematic of Operation

1 Plant Steam 60 psig (4.1 barg) dry and saturated.2 Coolant water at 32°F to 80°F (0°C to 26°C) at 40 psig (2.8 barg). (Flow rates based upon a distillate outlet temperature of190°F [88°C] and cooling water inlet temperature of 60°F [16°C]).

3Other electrical services must be specified at time of order.

Specifications


13

The Mueller PyroPure P6000 Series is Built to LastMueller PyroPure multiple-effect stills (MES) are the simplest, most reliable means of producing pyrogen-free water-

for-injection (WFI) that meets all U.S. Pharmacopoeia requirements. The MES is designed with efficiency in mind.

Because the system recovers the latent heat of vaporization occurring within its own process to heat feedwater and

uses feedwater as its primary source of cooling, the MES is an energy and money-saving model of ingenuity. Due to

the absence of moving parts, the PyroPure MES requires less maintenance and is much quieter than mechanical

compression stills. Multiple-effect stills also lack the seal and associated oil supply required by mechanical compression

stills; therefore, there is no danger of contamination due to seal breakdown associated with mechanical compression.

The PyroPure MES is manufactured according to FDA current Good Manufacturing Practices (cGMPs) and ASME-BPE

requirements.

Each PyroPure MES is designed to minimize operating costs associated with production of WFI by minimizing the

required utility steam and coolant consumption. This is accomplished by utilizing sources of energy within the various

process streams to preheat the feedwater and thus use the feedwater as a cooling source. Using the feedwater as a

coolant source also reduces the utility steam consumed to elevate the temperature of the feedwater. The feedwater

ultimately enters the tubes of the first effect evaporator where utility steam is applied to the shell to evaporate the

feedwater. The resulting steam produced is then directed to the separation column where a tangential inlet produces

centrifugal force that separates the entrained water droplets away from the pure steam. This pure steam is then used

as the heating source for the subsequent effect.

PyroPure Multiple-Effect Stills


• External evaporators access for inspection and

preventative maintenance on critical o-rings and gaskets.

• The separation columns contain no internal components

that require inspection or periodic maintenance.

• All maintenance, including replacement of critical

components, can be performed with only 24" of space

on all sides (including the top) of the equipment.

• ASME-BPE certified fittings are used throughout.

• WFI condensers have removable tube bundles

for easy cleaning and inspection of product

contact surfaces.

• Minimal instrumentation is required upon

operation of the equipment. Only two control

loops are needed which minimizes the

calibration required as well as the potential

for downtime.

• All elastomers in contact with feedwater and

product are provided with USP Class VI

certifications.

• All components are fully drainable including

the optional feedwater pump.


14

System ComponentsCondenser. PyroPure condensers have a double-tube-

sheet design that provides users with the efficiency of

heat exchange and at the same time ensures that pure

vapor and distillate will never come into contact with

feedwater and coolant. To facilitate maintenance, all

PyroPure condensers are mounted at an angle to allow

full drainage of the pure distillate through the distillate

outlet port installed at the lowest point of the vessel. The

condenser is designed to allow the removal of the U-tube

bundle, making it easy for the user to inspect the critical

pure distillate contact surfaces.

Controls. The standard control system is an Allen Bradley

PLC with an Allen Bradley operator interface mounted in

a NEMA rated panel. Ethernet is provided on the standard

control system to facilitate communications with adjacent

equipment or data archiving systems. Mueller can also

provide other Allen Bradley control components, as well

as control systems from Siemens and Mitsubishi. Control

and electrical panels are supplied with a UL 508a label.

Steam Separator. Mixture of water and vapor leaves the

evaporator at high velocity and enters the separator

through a tangential port, a natural vortex is formed. The

centrifugal force of the vortex separates water droplets

and contaminants out of the spiraling vapor. Pure vapor

rises up through the steam separator and out of the port

at the top of the separator. The steam separator has no

baffles or demister, there are no auxiliary surfaces for

condensation to collect and stagnate. Concerns over the

potential for bacterial growth are eliminated.

Preheaters. Each still is equipped with a preheater for

each effect to provide for maximum energy recovery and

efficiency. As the water flows under pressure from each

effect to the next the pressure of the water is reduced

which will result in “flashing” of the water into steam.

The preheater recovers this energy into the feedwater to

reduce the overall plant steam consumption.

Evaporator. The natural circulation design of the

PyroPure evaporator ensures maximum surface wetting,

eliminating the hot, dry areas that lead to the stress-

cracking associated with other designs. The tube bundle

creates a large heat transfer surface which vaporizes

feedwater on contact. The PyroPure multiple-effect still

has fully drainable external evaporators, eliminating the

need for the excess headroom required for evaporator

removal with other designs. The evaporator on the first

effect of the multiple-effect still is double tube-sheet to

prevent cross-contamination. All other effects have single-

tubesheet evaporators.

OptionsFeedwater Pump System. The feedwater pump system

enhances feedwater pressure and is required if feedwater

supply pressure is not equivalent to the plant steam

pressure. When purchased, the feedwater pump system

will be installed on the MES framework.

Pure Steam Option. Multiple-effect stills can be configured

to produce pure steam from the first effect. Simultaneous

WFI and pure steam production is also available.

As the pure steam is condensed in the shell side of the subsequent evaporator, the resulting WFI flows through

feedwater preheating devices and to the WFI condenser for subcooling to the required product temperature. Only

pure steam discharged from the last effect of the still is condensed in the product condenser. The final product as well

as the feedwater supplied to the still is measured for conductivity to ensure compliance with specifications.

Control of the multiple-effect still is accomplished by two control loops. The first control loop monitors the first effect

temperature and manipulates the plant steam control valve as needed to maintain the specified temperature. The second

control loop monitors the product temperature and manipulates a coolant control valve to maintain the specified product

temperature. Level switches in the separation columns provide control for the feedwater supply and provide alarm

capabilities to ensure that all effects are operating correctly. The control and operational simplicity results in a design

that requires no rotating equipment, flow measurement devices or pressure transmitters.

Models are available with 3 to 6 effects to provide the best solution for your application. Additional effects will result

in further reduced utility consumption while a minimum of effects will provide the lowest capital cost solution and

occupy the smallest footprint. All product contact surfaces are polished to 20 Ra maximum and electropolished. Surfaces

in contact with feedwater are polished to 25 Ra maximum. All surfaces in contact with feedwater and product are

manufactured from 316/316L stainless steel.

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The Mueller PyroPure P6000 Series is Built to Last

15


Sche

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16

Spec

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Water-for-Injection Systems

17


Mueller WFI Systems — Your Integrated Process SolutionWhen upgrading your water systems, consider the full range of products available from Mueller. We have partnered

with a variety of end users to provide an integrated system approach to their water system including the multiple-

effect stills, WFI storage tanks, closed loop cooling systems, and integrated control systems.

Advantages• Complete testing of all system components ensures system performance when the equipment arrives at site.

• An integrated control system reduces the number and complexity of control systems needed to operate your

water systems.

• Equipment documentation is consistent and presented as an integrated system. All test documentation, including

the functional requirements specification, software design specification, and factory acceptance test documents

are written with a system approach.

• Control of schedule is improved since all major components are manufactured at Mueller.

• Reduced labor and site construction required at your site.

• In many instances facility construction can proceed simultaneously with the water system construction.

18

Additional Skids Offered• Custom Process Skids• Alternative Fuel Skids• Filter Carts• Purewater Distiller• Hotwater• Pump Skids• Pretreatment

Custom Skidded SystemsPaul Mueller Company custom skidded systems are

designed to meet the specific requirements of your

application. These systems can incorporate all of

the monitoring equipment and control devices for

the system into a compact skid which is assembled,

integrated into a single PLC system, and tested at

the Springfield, Missouri, factory. Documentation

for all components are also incorporated into a

comprehensive turnover package.

Components and Instrumentation• WFI pump(s).

• Sanitary heat exchangers for trim heating or cooling as well as periodic sanitization.

• Conductivity analyzer for monitoring WFI quality.

• TOC analyzer for monitoring WFI quality.

• Level transmitters to monitor WFI tank level and activate still.

• Interconnecting piping valves and tubing between still, tank and WFI distribution skid.

• Flow and pressure instruments to monitor spray ball conditions and/or loop pressure.

• Steam in place (SIP) equipment to periodic sterilization cycle with temperature monitoring at all low point

drains.

Manufacturing and Test Facility Capabilities• Seven test bays equipped with coolant, utility steam, DI water, compressed air, and ability to accommodate a

variety of electrical configurations.

• Final assembly and test areas are climate controlled and isolated from welding and grinding areas.

• Carbon steel processing is not permitted in final assembly and test areas.

19

DocumentationMaterial Traceability The documentation for your system begins before

the first drawing is generated or the first welding

arc is struck. Material traceability is established with

the purchase and receipt inspection of materials

and is systematically maintained throughout the

manufacturing and assembly processes.

Process TraceabilityMany different processes take place during the fabrication of BioPharm equipment. Several methods are used to

document that the equipment has been designed, fabricated, assembled, and tested appropriately. These include:

• Borescope inspection and video capabilities. • Software design specification (as required).

• Factory testing procedures. • Master inspection traveler.

• Inspection records. • Weld records.

SubmittalsOnce your order is received, Mueller will send you

drawings for final approval. These documents define the

mechanical scope of supply and allow procurement and

fabrication of key components to proceed so the schedule

is minimized while ensuring the proper equipment will be

supplied. Subsequent submittals are provided for software

and functional testing details as required. We encourage

your comments and feedback on these documents to

ensure compliance with your project requirements.

Turnover Packages —Per BPE Requirements The resulting turnover package provides a well organized

and comprehensive validation reference that parallels

customer protocols. In additi on to the standard three-ring

binders, packages are also provided in CD/DVD formats.

IQ/OQ CapabilitiesPaul Mueller Company offers installation qualification (IQ)

and operational qualification (OQ) documents to support

our products. These are prepared concurrently with the

turnover package and provided for review at the time of

factory acceptance testing. Execution of these protocols can

be performed by Mueller service technicians at the time of

start-up and commissioning.

Documentation and Validation


20

ValidationAs a world leader in water and processing systems

for the finished pharmaceutical, bulk API, bio-

technology, medical device, and medical diagnostic

industries, Paul Mueller Company has extensive

industry experience preparing comprehensive

turnover documentation and validation packages.

Our various completed projects have withstood

scrutiny by numerous customers, independent

validation companies, numerous customers, and the

Food and Drug Administration (FDA).

As the pharmaceutical industry has evolved, so has our approach to validation. We are qualified to provide

documentation and validation compliance due to our extensive experience within the industry, our attention to

regulatory changes, and our capability to adapt to each of our customers’ specific needs. The completed installation

qualification (IQ) and operational qualification (OQ) documentation and validation packages provide documented

evidence that our systems are built and commissioned in accordance with user requirements specifications (URS),

functional requirements specifications (FRS) and detail design specifications (DDS), as well as FDA and cGMP standards.

Paul Mueller Company maintains a staff of professionals with considerable experience within the pharmaceutical

industries as well as broad educational backgrounds in quality, technical services, engineering, chemistry, and

microbiology to name a few. Since our validation and quality systems are integrated within the company infrastructure,

there are substantial benefits realized from shared databases along with our comprehensive understanding of the

equipment.

Industry ExperienceMueller has successfully provided documentation and validation assistance for large and small pharmaceutical and

biotech projects including:

• Hundreds of multiple-effect stills and pure steam generators.

• Seed train and production bioreactors, including controls and related process equipment.

• Process equipment for numerous buffer hold and preparation facilities consisting of as many as 40 vessels, as

well as the associated controls, electrical equipment, structure, utility piping, and process piping.

• Hundreds of vessels used in pharmaceutical and biotech service.

Factory Acceptance TestingMueller factory acceptance testing startsprior to your arrival on site with your reviewand approval of the test documents. Wealso pre-test the equipment prior to yourarrival. Any project specific requirementsoutlined in the functional specification anddesign specification documents will bechecked and tested as needed.

21

Mueller’s Product Support TeamOur MissionThe mission of Paul Mueller Company’s product support team is to meet and

exceed our customers’ expectations of value by setting the industry standard

for exceptional service to our customers. In support of this mission, we

maintain a technical staff of specialized technicians highly trained on our

products, vendor software, controls, and the various trade disciplines. Mueller

equipment is serving our customers worldwide. Factory trained technicians

are available to meet the needs of our customers and can normally be on-

site within 48 hours of notification.

Paul Mueller Company makes some of the most reliable equipment in service today. However, regardless of how well-

built a product is, continuous use without periodic inspection and maintenance can result in mechanical failure and

costly downtime. When you purchase Mueller equipment, you aren’t just buying a machine, you are investing in a

partnership. We work together to assure that your equipment continues to perform at its best for years to come.

Our ServicesStart-Up / CommissioningWhen your new Mueller equipment is fully installed, our service department will assist you with scheduling a start-up

by a factory technician. The technician will inspect the equipment for any damage which may have occurred during

shipping or installation. The technician will then inspect the installation and make certain that the utilities meet the

minimum requirements, and make recommendations to assure you have the most efficient installation. The equipment

will then be operated to challenge all of the alarm conditions and operational parameters according to the factory

acceptance test (FAT). Basic operation and maintenance training will be provided to any available personnel.

Factory Training SeminarsOperation and maintenance training seminars can be held at your

facility as needed. These seminars include both classroom as well

as hands-on training. During classroom discussions, participants

are able to learn from the experience of the factory technicians.

Many who have attended past seminars have commented that this

is the most valuable training they have ever invested in.

On-Site Troubleshooting and RepairMueller factory technicians are available for scheduled or

unexpected maintenance repairs. Our technicians have years of

experience working with all types of Mueller equipment. Their

understanding of the control logic for the equipment allows them

to troubleshoot nearly any situation promptly. Many situations

can be resolved over the phone; however, some situations may

require an experienced eye on-site to resolve the problem with-

out delay.

When the need arises, you can depend on the knowledge and

experience of Mueller product support technicians to get your

equipment back in operation as soon as possible.


22

Replacement Parts Each documentation package includes a list of recommended replacement parts that will minimize downtime in the

event of a failure. Mueller stocks the most critical replacement parts for your equipment. Our parts specialists literally

provide replacement parts to you as quickly as possible when your machine is down.

Technical Support Via Phone, Fax, or EmailThere is never a charge for technical support from the factory via telephone, fax, or email. Your experienced operators

and our factory technicians are able to resolve most issues over the phone, which saves you time and money. Please

call 1-888-281-5800, send a facsimile to 417-575-9662, or email us at [email protected].

Technical Support AgreementsA Mueller technical support agreement (TSA) establishes a preventative maintenance plan that can be customized to

meet your specific operational and equipment needs. The goal is to minimize downtime caused by mechanical failure.

The TSA allows a factory technician to visit your facility periodically throughout the year to thoroughly inspect your

equipment. During a TSA visit, the technician will verify all operational parameters and challenge each alarm in

accordance with the original FAT to verify your equipment is in good working order. The technician will provide a

detailed service report that documents the operational condition of your equipment during each visit, explains all

work performed, and identifies any defects which could not be repaired during the allotted time. The service report

becomes an on-going document for your equipment’s permanent records. During the TSA visit, the technician can

also provide basic training to new employees or advanced training to more experienced employees.

We are pleased to offer you this enhanced service, and we look forward to helping you minimize unnecessary downtime.

For more detailed information or a quote for a Mueller technical support agreement based on your specific needs, contact

Mueller’s Product Support Team at 1-888-281-5800 or email us at [email protected].

Technical Support Agreement ServicesMueller technical support agreements can be set up to provide quarterly, semi-annual, or annual service calls. The

contract period begins when you sign, and it includes the following:

• Visual and operational inspection of all major components and assemblies.

• Visual and operational inspection of select accessory components.

• Visual and operational testing of all safety devices.

• Performance testing with a complete service report for your records.

• Factory training for equipment operators and your service personnel.

• Recommendations for preventative repairs.

“It has been our privilege to place the skills and techniques ofPaul Mueller Company at the service of many of the nation’s leadingcompanies. It would be a further privilege to serve your company.”

PyroPure Equipment — Proudly built in the heartland ofAmerica and shipped worldwide for over 30 years.

©2009-2014 Paul Mueller Company PP-2163-4

1600 West Phelps Street • Springfield, Missouri 65802, U.S.A.Phone: 417-575-9000 • 1-800-MUELLER • Fax: 417-575-9662www.paulmueller.com • Email: [email protected]

pp-2163-4 paul mueller company pyropure...1.5" tc 2" tc 2" tc 3" tc 3" tc...

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